"The U.S. Food and Drug Administration on Wednesday approved a request by Danco Laboratories to expand authorized use of its abortion pill Mifeprex (mifepristone), formerly known as RU-486, to 70 days of gestation from 49 days.
In five clinical studies of depo-subQ provera (medroxyprogesterone acetate) 104 involving 2,325 women (282 treated for up to 6 months, 1,780 treated for up to 1 year and 263 treated for up to 2 years), 9% of women discontinued treatment for adverse reactions. Among these 212 women, the most common reasons for discontinuation were:
- Uterine bleeding irregularities (35%, n=75)
- Increased weight (18%, n=39)
- Decreased libido (11%, n=23)
- Acne (10%, n=21)
- Injection site reactions (6%, n=12)
Adverse reactions reported by 5% or more of all women in these clinical trials included:
- Headache (9%)
- Intermenstrual bleeding (7%)
- Increased weight (6%)
- Amenorrhea (6%)
- Injection site reactions (5%)
Adverse reactions reported by 1% to < 5% of all women in these clinical trials included:
Nervous system disorders: dizziness, insomnia
Reproductive system and breast disorders: breast pain, breast tenderness, menometrorrhagia, menorrhagia, menstruation irregular, uterine hemorrhage, vaginal hemorrhage
Skin disorders: acne
Vascular disorders: hot flushes
There have been rare cases of osteoporosis including osteoporotic fractures reported postmarketing in patients taking DEPO-PROVERA Contraceptive Injection. In addition, infrequent voluntary reports of anaphylaxis and anaphylactoid reaction have been received associated with use of Depo-Provera CI (150 mg).
The following additional reactions have been reported with Depo-Provera Contraceptive Injection and may occur with use of depo-subQ provera 104:
Cardiac disorders: tachycardia
Gastrointestinal disorders: gastrointestinal disturbances, rectal bleeding
Hepato-biliary disorders: jaundice
Immune system disorders: allergic reaction
Investigations: decreased glucose tolerance
Psychiatric disorders: increased libido, nervousness
Reproductive system and breast disorders: breast lumps, galactorrhea, nipple discharge or bleeding, oligomenorrhea, prevention of lactation, prolonged anovulation, unexpected pregnancy, uterine hyperplasia, vaginal cyst
Read the Depo-SubQ Provera (medroxyprogesterone acetate) Side Effects Center for a complete guide to possible side effects
No drug-drug interaction studies have been conducted with depo-subQ provera (medroxyprogesterone acetate) 104. Aminoglutethimide administered concomitantly with depo-subQ provera (medroxyprogesterone acetate) 104 may significantly decrease the serum concentrations of MPA.
Read the Depo-SubQ Provera Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 7/28/2009
Additional Depo-SubQ Provera Information
Depo-SubQ Provera - User Reviews
Depo-SubQ Provera User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.